- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03024164
Stroke Registration of Young Adults in China (REACH)
February 29, 2024 updated by: Yi Yang
This is a multi-center, prospective,continuous registry study.
The investigators will include 3000 young adult (18-45 years old) patients with confirmed first-ever acute ischemic stroke in China.
The main purpose of this study is to build the study cohort of young ischemic stroke patients in China, and to compare the prognosis and stroke recurrence of young patients with different ischemic stroke subtypes.
Secondary objectives are trying to find biomarkers of stroke recurrence.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Approximately 10%-14% of all ischemic strokes occur in young adults ages 18 to 45 years old.
Stroke etiology in this population differs by geographic region and has greater heterogeneity than in older individuals.
Ascertain the definite etiologic classification in this young patients might be the key point to prevent the stroke recurrence and reduce the stroke burden.
Advances in stroke diagnostic tests, particularly neuroimaging, refinement in classification schema.
In this multi-center registry study conducted in China, we determine to explore the difference of prognosis and stroke recurrence of young patients with different ischemic stroke subtypes.
Study Type
Observational
Enrollment (Estimated)
3000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yi Yang, MD,PhD
- Phone Number: +86-18186870008
- Email: doctor_yangyi@hotmail.com
Study Contact Backup
- Name: Zhenni Guo, MD
- Phone Number: +86-18186872986
- Email: zhen1ni2@163.com
Study Locations
-
-
Jilin
-
Changchun, Jilin, China, 130000
- Recruiting
- First Hospital of Jilin University
-
Contact:
- Yi Yang, MD, PhD
- Phone Number: +86-18186870008
- Email: doctoryangyi@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Young adult patients who had their first-ever ischemic stroke symptoms within 72 hours and visited one of the 22 participating medical centers in People's Republic of China.
Description
Inclusion Criteria:
- Age 18 through 45 years, both genders
- First-ever acute ischemic stroke
- Onset of symptoms within 72 hours of inclusion
- Willing to participate in follow-up visits
Exclusion Criteria:
- Silent stroke
- Failure to give their informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Young adult stroke patients
Young adult (18-45 years old) patients with confirmed first-ever acute ischemic stroke
|
Treatment following current guidelines
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stroke recurrence
Time Frame: 1 year
|
Percentage of patients with the 1 year new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage)
|
1 year
|
Post-stroke disability
Time Frame: 3 months
|
Modified Rankin Scale score changes (continuous) and dichotomized at percentage with score 0-2 vs. 3-6 at 3-month follow-up.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiovascular death
Time Frame: 3 months, 6 months and 1 year
|
Percentage of patients with the 3-month, 6-month and 1 year cardiovascular death caused by any event of the following: Any stroke (ischemic or hemorrhage), sudden cardiac death, acute myocardial infarction, heart failure, and other cardiovascular death including pulmonary embolism, rupture of aortic aneurysm, cardiovascular interventional therapy, and peripheral arterial disease.
|
3 months, 6 months and 1 year
|
Other cardiovascular event
Time Frame: 3 months, 6 months and 1 year
|
Percentage of patients with the 3-month, 6-month and 1 year other cardiovascular event including non-lethal myocardial infarction, and non fatal heart failure.
|
3 months, 6 months and 1 year
|
Other systemic embolism
Time Frame: 3 months, 6 months and 1 year
|
Percentage of patients with the 3-month, 6-month and 1 year other systemic embolism except for cerebral artery, coronary artery, and pulmonary artery.
Such as mesenteric arterial embolism,splenic artery embolization.
|
3 months, 6 months and 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 26, 2017
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
July 31, 2025
Study Registration Dates
First Submitted
January 15, 2017
First Submitted That Met QC Criteria
January 17, 2017
First Posted (Estimated)
January 18, 2017
Study Record Updates
Last Update Posted (Estimated)
March 1, 2024
Last Update Submitted That Met QC Criteria
February 29, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REACH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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